Specialist QA
Job Opportunity: Quality Assurance Specialist (3138088)
Location: Puerto Rico (Hybrid work – Administrative Shift)
Duration: Approximately One Year
Positions Available: 1
Summary
Our client is seeking a highly motivated Quality Assurance Specialist to support its Quality Assurance program. The ideal candidate will work under minimal supervision and be responsible for ensuring compliance with regulatory requirements and internal quality standards. This hybrid opportunity is open to residents of Puerto Rico and requires availability during weekends as needed.
Preferred Qualifications
The ideal candidate will possess:
- Experience in New Product Introduction (NPI)
- Proficiency in validation, automation, and change control processes
- Familiarity with systems such as DAI process, PASx/MES, Risk Assessment, MAXIMO, SAP, and LIMS
- Flexibility to support weekend operations
Key Responsibilities
- Review and approve Master Production Records (MPs)
- Approve process validation protocols and reports
- Serve as QA representative on incident triage teams
- Approve Environmental Characterization Reports
- Oversee and release sanitary utility systems
- Approve planned incidents
- Represent QA on New Product Introduction (NPI) teams
- Lead quality investigations and site audits
- Own and maintain site quality program procedures
- Act as designee for the QA Manager during local Change Control Review Board (CCRB) meetings
- Review and assess Risk Assessments
- Support Automation, Facilities, and Environmental Programs
- Review and approve Work Orders and EMS/BMS alarms
- Approve Nonconformance (NC) investigations and CAPA records
- Approve and manage Change Controls
- Provide lot disposition and lot release for shipment
Education / Licenses
Candidates must meet one of the following minimum qualifications:
- Doctorate degree, or
- Master’s degree with 3 years of directly related experience, or
- Bachelor’s degree with 5 years of directly related experience, or
- Associate’s degree with 10 years of directly related experience, or
- High School Diploma / GED with 12 years of directly related experience
Core Competencies & Skills
- Strong project management and organizational skills
- Ability to initiate and lead cross-functional teams
- Skilled in leadership, influence, and negotiation
- Advanced knowledge of manufacturing, distribution, QA, QAL, validation, and process development
- Proven experience interacting with regulatory agencies
- Proficiency in MS Office tools: Word, Excel, PowerPoint, and database applications
- Excellent written and verbal communication, facilitation, and presentation skills
- Strong independent work ethic and ability to collaborate across all levels of the organization
- Expertise in data trending, compliance evaluation, and quality metrics analysis
📩 Interested in making a direct impact in the pharmaceutical and biotech industry?
We invite qualified candidates to apply through the job description link with an updated resume to take the next step in their career journey.